TEL AVIV, Israel, Nov. 4, 2021 /PRNewswire/ --BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, today announced an oral presentation and three poster presentations at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition, which is being held December 11-14, 2021 in Atlanta, GA, and virtually.
The oral presentation will elaborate on the successful results of the Company's GENESIS Phase 3 pivotal trial. The study showed highly significant and clinically meaningful results supporting the use of Motixafortide on top of G-CSF for mobilization of stem cells for subsequent collection and transplantation in patients with multiple myeloma. In addition, the poster presentations will show that extended inhibition of the CXCR4 receptor by Motixafortide results in the mobilization of high numbers of stem cells, including specific sub-populations, which were correlated with reduced time to engraftment when infused in high numbers.
The Company is also presenting findings from in-vivo and in-vitro pre-clinical studies demonstrating that Motixafortide acts as an immunomodulator by affecting the biology of regulatory T cells (Tregs), supporting biomarker findings from the Company's COMBAT Phase 2 study in pancreatic cancer patients.
"We are very pleased with the breadth of our oral and poster presentations at this year's ASH meeting, which reflect the versatility of Motixafortide as the potential backbone of promising new treatments for both hematological and solid tumor cancers," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Of particular note is the oral presentation on the outstanding results from our GENESIS Phase 3 pivotal study in stem cell mobilization demonstrating that Motixafortide effectively mobilizes a high number of cells enabling ~90% of patients to undergo transplantation following a single administration of Motixafortide and a single apheresis session. In addition, the high number of cells mobilized by Motixafortide enables infusion of an optimal number of cells, which could result in faster time to engraftment, and also allows for cryopreservation for future transplantation(s). These results, together with our recently completed successful pharmacoeconomic study, strongly support our view that Motixafortide on top of G-CSF can become the new standard of care in SCM, if approved, to the benefit of patients and payers alike. We look forward to submitting an NDA in the first half of next year, as previously communicated."
Further details of the presentations are provided below.
Oral Presentation
Title: Motixafortide (BL-8040) and G-CSF Versus Placebo and G-CSF to Mobilize Hematopoietic Stem Cells for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma: The GENESIS Trial
Date: Sunday, December 12, 2021
Time: 12:00 PM
Location: Georgia World Congress Center, Hall A1
This oral presentation describes the GENESIS Phase 3 pivotal trial design, endpoints and results. The GENESIS study was a double blind, placebo controlled, multicenter trial, in which 122 patients were randomized (2:1) to receive either Motixafortide + G-CSF or placebo + G-CSF for stem cell mobilization prior to stem cell transplant in multiple myeloma patients. Total CD34+ cells/kg were analyzed on site to determine if patients mobilized to the goal and all samples were subsequently sent for assessment by a central laboratory. The number of CD34+ cells infused was determined independently by each investigator according to local practice.
The study concluded that a single administration of Motixafortide on top of G-CSF significantly increased the proportion of patients mobilizing 6x106 CD34+ cells/kg for stem cell transplantation (92.5%) vs G-CSF alone (26.2%) in up to two apheresis days (p<0.0001), while enabling 88.8% to collect 6x106 CD34+ cells/kg in just one apheresis day (vs 9.5% with G-CSF alone; p<0.0001). In addition, the median number of hematopoietic stem cells mobilized in one apheresis day with Motixafortide + G-CSF was 10.8x106 CD34+cells/kg vs 2.1x106 CD34+ cells/kg with G-CSF alone.
Poster Presentations
Title:Autologous Hematopoietic Cell Transplantation with Higher Doses of CD34+ Cells and Specific CD34+ Subsets Mobilized with Motixafortide and/or G-CSF is Associated with Rapid Engraftment A Post-hoc Analysis of the GENESIS Trial
Date: Sunday, December 12, 2021
Time: 6:00 PM - 8:00 PM
The CD34+ hematopoietic stem and progenitor cell (HSPC) dose infused during stem cell transplantation remains one of the most reliable clinical parameters to predict quality of engraftment. A minimum stem cell dose of 2-2.5x106 CD34+ cells/kg is considered necessary for reliable engraftment, while optimal doses of 5-6x106 CD34+ cells/kg are associated with faster engraftment, as well as fewer transfusions, infections, and antibiotic days.
An analysis was performed using pooled data from all patients in the GENESIS trial to evaluate time to engraftment based on the total number of CD34+ cells/kg infused, as well as specific numbers of CD34+ cell sub-populations infused.
The addition of Motixafortide to G-CSF enabled significantly more CD34+ cells to be collected in one apheresis (median 10.8x106 CD34+ cells/kg) compared to G-CSF alone (2.1x106 CD34+ cells/kg), as well as 3.5-5.6 fold higher numbers of hematopoietic stem cells (HSCs), multipotent progenitors (MPPs), common myeloid progenitors (CMPs) and granulocyte and macrophage progenitors (GMPs) (all p-values <0.0004). A dose response was observed with a significant correlation between faster time to engraftment and infusion of higher number of total CD34+ HSPC doses (6x106 CD34+ cells/kg) and combined HSC, MPP, CMP and GMP subsets. The high number of CD34+ cells/kg mobilized with Motixafortide on top of G-CSF enables the potential infusion of 6x106 CD34+ cells/kg, as well as cryopreservation of cells for later use.
Title: Immunophenotypic and Single-Cell Transcriptional Profiling of CD34+ Hematopoietic Stem and Progenitor Cells Mobilized with Motixafortide (BL-8040) and G-CSF Versus Plerixafor and GCSF Versus Placebo and G-CSF: A Correlative Study of the GENESIS Trial
Date: Monday, December 13, 2021
Time: 6:00 PM - 8:00 PM
CD34 expression remains the most common immunophenotypic cell surface marker defining human hematopoietic stem and progenitor cells (HSPCs). The addition of CXCR4 inhibitors to G-CSF has increased mobilization of CD34+ HSPCs for stem cell transplantation; yet the effect of CXCR4 inhibition, with or without G-CSF, on mobilization of specific immunophenotypic and transcriptional CD34+ HSPC subsets is not well-characterized.
Motixafortide is a novel cyclic peptide CXCR4 inhibitor with a low receptor-off rate and extended in vivo action when compared to plerixafor. GENESIS Phase 3 trial patients were prospectively randomized (2:1) to receive either Motixafortide + G-CSF or placebo + G-CSF for HSPC mobilization. Demographically similar multiple myeloma patients undergoing mobilization with plerixafor + G-CSF prior to stem cell transplant were prospectively enrolled in a separate tissue banking protocol.
Extended CXCR4 inhibition with Motixafortide + G-CSF mobilized significantly higher numbers of combined CD34+ HSCs, MPPs and CMPs compared to plerixafor + G-CSF or G-CSF alone (p<0.05). Additionally, Motixafortide + G-CSF mobilized a 10.5 fold higher number of immunophenotypically primitive CD34+ HSCs capable of broad multilineage hematopoietic reconstitution compared to G-CSF alone (p<0.0001) and similar numbers compared to plerixafor + G-CSF. Furthermore, lack of CXCR4 inhibition resulted in mobilization of more-differentiated HCSs, whereas extended CXCR4 inhibition with Motixafortide + G-CSF (but not plerixafor + G-CSF) mobilized a unique MPP-III subset expressing genes specifically related to leukocyte differentiation.
Title: The High Affinity CXCR4 Inhibitor, BL-8040, Impairs the Infiltration, Migration, Viability and Differentiation of Regulatory T Cells
Date: Sunday, December 12, 2021
Time: 6:00 PM - 8:00 PM
This poster describes results of pre-clinical in-vivo and in-vitro studies demonstrating that Motixafortide potentially acts as an immunomodulator by affecting the biology of regulatory T cells. Motixafortide reduced the amount of infiltrating Tregs into the tumors, impaired the migration of Tregs toward CXCL12 and induced Tregs cell death. Furthermore, Motixafortide was found to inhibit the differentiation of nave CD4 T cells toward Tregs.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.
The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation, has reported positive results from a pre-planned pharmacoeconomic study, and is currently in preparations for an NDA submission. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to Motixafortide), and is currently being studied in combination with LIBTAYO and chemotherapy as a first-line PDAC therapy.
BioLineRx is also developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.
For additional information on BioLineRx, please visit the Company's website at http://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the COVID-19 pandemic; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on February 23, 2021. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contact:
Tim McCarthyLifeSci Advisors, LLC+1-212-915-2564[emailprotected]
or
Moran MeirLifeSci Advisors, LLC+972-54-476-4945[emailprotected]
SOURCE BioLineRx Ltd.
See the original post:
BioLineRx Announces an Oral Presentation and Three Poster Presentations at the 63rd American Society of Hematology (ASH) Annual Meeting &...
- CIRI calls for safety advice revamp after health concerns raised by 3D printing emission research - 3D Printing Industry - October 13th, 2022
- Global Adult Stem Cells Market | Expected to Reach USD 9.45 Billion and Compound Annual Growth Rate (CAGR) is - openPR - October 4th, 2022
- The cloudy connection between fragile X and cancer - Spectrum - October 4th, 2022
- CBD And CBG Show Promising Results In Treating Glioblastoma Brain Tumors - The Fresh Toast - June 22nd, 2022
- How Protein Nanoparticle Vaccines Have The Potential To Be Developed Into 'Safer' Covid-19 Vaccines: Study - ABP Live - June 4th, 2022
- SpaceX capsule returns to Earth with first all-private space station crew Spaceflight Now - Spaceflight Now - May 2nd, 2022
- Identifying Missing Links - and Why Certain Drugs Don't Work - in Alzhiemer's - BioSpace - April 6th, 2022
- Axion BioSystems Acquires Live-Cell Imaging Innovator CytoSMART Technologies - Business Wire - March 25th, 2022
- Avra, Inc. Completes its Merger with Springs Rejuvenation, LLC, a Stem Cell and Anti-Aging Treatment Company - GlobeNewswire - December 24th, 2021
- From asthma to cancer to infertility, the new treatments, jabs and meds making us healthier... - The Sun - November 22nd, 2021
- EdiGene to Present Latest Research on A Novel Surface Marker and Migration of Hematopoietic Stem Cell (HSC) That Could Enhance HSC Gene Therapy and... - November 8th, 2021
- Editas Medicine to Present Data Demonstrating Progress Towards Transformative Gene Editing Medicines for the Treatment of Hemoglobinopathies and... - November 8th, 2021
- MorphoSys to Present MANIFEST and RE-MIND2 Data from Expanded Hematology-Oncology Portfolio at the 2021 American Society of Hematology (ASH) Annual... - November 8th, 2021
- Precision BioSciences Announces Two Oral Presentations Highlighting Updated Interim Data from Lead PBCAR0191 CAR T Immunotherapy for Relapsed and... - November 8th, 2021
- Role of Stem Cells in Treatment of Neurological Disorder - October 16th, 2021
- A plant that 'cannot die' reveals its genetic secrets - The Independent - August 5th, 2021
- Exploring science with a new generation of girls - US Embassy in Georgia - February 11th, 2021
- Stemcell Renewal Elixir GEORGIA LOUISE - September 25th, 2020
- COVID is shifting the conversation about the medical application of CBD - Open Access Government - September 22nd, 2020
- Robert E. Windsor, MD, is being recognized by Continental Who's Who - PRNewswire - September 22nd, 2020
- Cytovia Therapeutics, Inc appoints Dr. Wei Li as Chief Scientific Officer to accelerate the development of iPSC CAR-NK Cell Therapy for Cancer - Yahoo... - June 6th, 2020
- Athens hospital using biologic treatment on COVID-19 patients - Online Athens - June 2nd, 2020
- Study reveals birth defects caused by flame retardant - University of Georgia - June 2nd, 2020
- Novant Health Initiates Phase 2b/3 Trial with CytoDyns Leronlimab for Severely and Critically Ill COVID-19 Patients - Yahoo Finance - May 11th, 2020
- CytoDyn Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries -... - May 5th, 2020
- Covid-19 has shuttered labs. It could put a generation of researchers at risk - STAT - May 5th, 2020
- CytoDyn (OTC: CYDY) Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable... - May 5th, 2020
- Stem Cell Therapy in Atlanta, GA - sipapain.com - February 3rd, 2020
- Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market Industry Trends and Forecast to 2025 - News Distribute - December 27th, 2019
- Transition to exhaustion: clues for cancer immunotherapy - 7thSpace Interactive - December 5th, 2019
- Autologous Stem Cell And Non Stem Cell Based Therapies Market Opportunity Analysis and Industry Forecast up to 2026 - Guru Online News - November 20th, 2019
- Georgia solar factory scores on tariffs; others in industry take a hit - Atlanta Journal Constitution - September 23rd, 2019
- Georgia Stem Cells | Stem Cell TV - September 7th, 2019
- Current Strategies and Challenges for Purification of ... - March 6th, 2019
- Stem Cell Savannah Georgia 31401 - January 20th, 2019
- Atlanta, Georgia Stem Cell Transplant, Marietta, Berkeley ... - September 7th, 2018
- Placenta | Amniotic tissue is not stem cell therapy - Dr ... - July 17th, 2018
- Turning Skin Cells Into Brain Cells - 06/28/2012 - October 1st, 2017
- This Wasp's Larvae Sometimes Grow Hundreds of Soldier ClonesBut Why? - Entomology Today - August 21st, 2017
- Atlanta Stem Cell Therapy | Georgia Stem Cell Treatments ... - October 7th, 2016
- Storing Stem Cells In Teeth For Your Familys Future Health - October 31st, 2015
- Scientists Turn Back the Clock on Adult Stem Cells Aging ... - October 16th, 2015
- Lymphoid Cells, Lymphoid Stem Cells - AllCells.com - October 11th, 2015
- Using Stem Cells in Teeth for Future Use in Developing ... - September 30th, 2015
- Human Mesenchymal Stem Cells & Media - September 25th, 2015
- Asymmetrex Plans to Report Results From Adult Stem Cell ... - August 2nd, 2015
- Stem Cells - Lonza - July 10th, 2015
- Global Stem Cells Group Announces First Stem Cell Training ... - June 3rd, 2015
- Effective Hematopoietic Mesenchymal Stem Cell Therapies - April 25th, 2015
- Stem Cells Hashimoto's Thyroiditis - April 22nd, 2015
- Welcome to Atlanta Stem Cell Treatment - April 9th, 2015
- Stem Cells Thailand - Stem Cell Therapy Thailand - March 27th, 2015
- Stem Cell Institute Los Angeles Chronic Pain Treatments - March 27th, 2015
- Graphene Shows Promise In Eradication Of Stem Cancer Cells - March 10th, 2015
- Stem Cell Treatment India,Stem Cell Treatment India,Cost ... - March 8th, 2015
- Bone Marrow & Stem Cell Transplant Center | Atlanta, GA ... - November 16th, 2014
- Biological fat with a sugar attached essential to maintaining the brain's supply of stem cells - November 3rd, 2014
- How stress ups depression risk - October 21st, 2014
- Protein appears to protect against bone loss in arthritis - September 13th, 2014
- Boron Facilitates Stem Cell Growth and Development in Corn - August 29th, 2014
- Georgia (Stem Cell) - what-when-how - August 26th, 2014
- Stem Cells in GA - Georgia Bio - August 25th, 2014
- Stem Cells COPD | Stem Cell Treatments - August 23rd, 2014
- Stem Cells Atlanta GA, Stem Cell Therapy, Dental Stem Cells - August 22nd, 2014
- Stem cells reveal how illness-linked genetic variation affects neurons - August 22nd, 2014